With over 20 years of experience from roles at Lundbeck, Zealand Pharma and UNEEG Medical, Mads Bjerregaard was recruited to help drive SynActs goal of advancing resomelagon towards market. He will play a key role in shaping the company’s partnering and commercial strategy as key clinical studies progress.
According to the CEO Jeppe Ovlesen the appointment marks an important step in executing SynAct’s broader strategy to unlock the full potential of resomelagon across multiple indications. – With Mads on board as part of our Copenhagen-based team, we are strengthening our ability to develop and execute on our commercial and partnering opportunities.
Øvlesen and Bjerregaard recently visited BioStock's studio to discuss the company's latest progress. Watch the interview here.
With an extended financial runway into 2027, ongoing clinical progress, and reinforced leadership, SynAct Pharma appears well-positioned to accelerate its next phase of development and business expansion.
CBO comments
Following the appointment, BioStock spoke with Mads Bjerregaard about his background, priorities and vision for SynActs future.
Building global partnerships for inflammation resolution
Mads, you have recently been appointed Chief Business Officer at SynAct. Can you tell us about your background and what your main priorities will be in your new position?
- I'm very excited to have joined the team at SynAct Pharma in the role of Chief Business Officer. I have more than 20 years of experience in commercial roles in global pharma, clinical-stage biotech, and medical technology companies, working to bring technologies from clinic to market. My main priority at SynAct Pharma is to secure partnerships that will enable our lead program, resomelagon, to be utilized in the best possible manner for patients globally.
- Resomelagon is a potential first-in-class novel therapeutic opportunity that enables key immune cell modulation to reduce inflammatory activity and promote resolution — without suppressing the immune system. This could help millions of patients overcome periods of elevated inflammation without the side effects associated with immunosuppression.
- To fully explore and commercialize this opportunity, we will be looking for partners across a broad range of therapeutic and geographical perspectives.
Joining at a key inflection point for SynAct
What motivated you to join SynAct at this particular stage, and what excites you most about the company's potential?
- I was drawn to SynAct because the company is at a pivotal point - scientifically, clinically, and strategically. The progress with resomelagon already demonstrates how modulation of the melanocortin system can open a completely new therapeutic avenue for inflammatory and autoimmune diseases.
– What excites me most is the combination of SynAct's focused approach, the quality of its team, and the potential breadth of applications for resomelagon.
Applying lessons from big pharma and biotech
Looking back at your work at Lundbeck, Zealand Pharma, and UNEEG Medical, which lessons learned are most relevant to SynAct's business development strategy?
- I have had the fortune of working with innovative technologies across therapeutic areas — from early clinical development to post-launch uptake.
– You need to focus on opportunities that sit at the intersection of proven clinical benefit, competitive pricing and reimbursement, and scalability. We believe that this is achievable with resomelagon.
Two development tracks driving future partnerships
As SynAct advances the ADVANCE Phase IIb trial in rheumatoid arthritis, what key partnering or business-development milestones should investors watch for over the next 12 months?
– We are in the fortunate position to have two parallel development tracks for resomelagon, each representing a major opportunity to improve patient outcomes — and both will be key discussion points in upcoming business development activities.
First, our phase IIb ADVANCE study in rheumatoid arthritis is actively recruiting at sites in Europe and the US
– These results will be a major catalyst for understanding resomelagon's potential across different stages of the disease and for initiating phase III and commercialization discussions.
– In parallel, we are developing resomelagon for host-directed viral inflammation, where a previous phase IIa study in hospitalized COVID-19 patients in Brazil demonstrated faster recovery, lower ICU admission rates, and shorter hospital stays.
- Building on this, we have initiated a Dengue virus study in Brazil, expected to begin recruiting early next year during the Dengue season.
- We believe that host-directed viral inflammation could become a significant future opportunity for resomelagon and another catalyst for partnership discussions.
Partnering for long-term value creation
What criteria will you use to identify and select potential partners, and how do you intend to structure collaborations so that SynAct retains long-term value while accelerating market access?
- When identifying partners, we look for alignment in scientific vision, geographic reach, and proven capabilities to develop and launch novel therapeutics in competitive markets.
- There are many stakeholders involved - from clinicians and patients to regulators and payers - and building trust in the use of resomelagon across these groups is essential.
As for collaboration structures, there are many possible approaches, but what's critical is a mutual commitment to the compound's long-term value.
Laying the groundwork for market access
Market access planning can make or break a launch. What steps is SynAct taking now, well before Phase III, to prepare?
- I strongly believe that a good market access strategy should be built early, aligning unmet medical needs with clear positioning for competitive pricing and reimbursement five years into the future.
- Specifically, we are evaluating value thresholds through health economic modeling, including benchmarks from biosimilar biological DMARDs for rheumatoid arthritis and FDA-approved treatments for severe or high-risk COVID-19.
Market access planning will be a central part of our discussions with potential partners as we move forward — it's essential for maximizing both patient access and commercial potential.
Expanding the opportunity for resomelagon
Looking ahead, where do you see the greatest long-term opportunities for SynAct and resomelagon over the next few years?
– Resomelagon represents a platform opportunity across both autoimmune and infection-driven inflammation.
– Our near-term focus is firmly on delivering clinical proof with the Phase IIb ADVANCE trial in rheumatoid arthritis designed to demonstrate resomelagon's ability to achieve disease control without immune suppression. This may help millions of patients treated for rheumatoid arthritis.
– In parallel, we are advancing the host-directed viral inflammation program, starting with Dengue, which could open an entirely new therapeutic option in infection-driven hyperinflammation for millions of patients being hospitalized annually due to viral infections like Covid, Influenza, RSV, and Dengue.
- Looking longer term, the unique mechanism of resolution biology gives us the option to expand into additional inflammatory or autoimmune indications where restoring immune balance is key.
- In essence, we want to pioneer the future of inflammation care - turning resolution therapy into reality for patients, while creating sustainable long-term value for our shareholders.
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